Complies with 93/42/EEC Medical Devices Directive – Classification: Class I, Rule 1
Certified to EN ISO 13485 (medical devices – quality management systems)
Certified to ISO 14971 / EN 14971 (application of risk management to medical devices)
Certified to ISO 9001 / EN 9001 (quality management systems)
Complies with 93/42/EEC Medical Devices Directive – Classification: Class I, Rule 1
Certified to EN ISO 13485 (medical devices – quality management systems)
Certified to ISO 14971 / EN 14971 (application of risk management to medical devices)
Certified to ISO 9001 / EN 9001 (quality management systems)
Complies with EN 60601 1 (medical electrical equipment – general requirements for basic safety and essential performance)
Description
The DARAY X400 LED wall mounted examination light (X400LW) is part of the DARAY X4 Series of premium LED examination lights designed for general medical diagnosis and procedures. The wall-mounted configuration combines a large, high-intensity light field with variable intensity control (5–100%), excellent colour rendering (CRI 95, R9 88) and BioProtect® antimicrobial coating on all painted surfaces to support infection control. The X400LW features a smooth, fully-enclosed light-head and spring-balanced suspension arm system for effortless repositioning and precise illumination at the point of care. With energy-efficient LED technology, a long average working life of more than 50,000 hours and a comprehensive 5-year warranty, it offers a low total cost of ownership and a robust, environmentally considerate lighting solution for clinics, hospitals and other healthcare environments.
Bnefits
Premium-quality LED examination light for general medical diagnosis and procedures
Wall-mounted configuration (X400LW) with versatile spring-balanced arm for effortless positioning
Variable light intensity from approximately 5% to 100% for precise control of illumination
High light output: approximately 120,000 lux at 0.5 m and 40,000 lux at 1.0 m for clear visualisation
Complies with EN 60601 1 (medical electrical equipment – general requirements for basic safety and essential performance)
Complies with EN 60601 1 2 (medical electrical equipment – electromagnetic compatibility)
Complies with EN 60601 1 6 (medical electrical equipment – usability)
Complies with EN 60601 2 41 (particular requirements for the safety of surgical luminaires and luminaires for diagnosis, as applicable)
Complies with EN 1041 (information supplied by the manufacturer of medical devices)
Complies with EN 60598 2 25 (particular requirements for luminaires for use in clinical areas of hospitals and health care buildings)
Meets 2014/35/EU Low Voltage Directive requirements
GMDN code: 12276 (examination light, non Sterile, reusable, as stated in product datasheet)
NHS E Class codes: FBU, FKR (per X4 Series datasheet)
Complies with EN 60601 1 2 (medical electrical equipment – electromagnetic compatibility)
Complies with EN 60601 1 6 (medical electrical equipment – usability)
Complies with EN 60601 2 41 (particular requirements for the safety of surgical luminaires and luminaires for diagnosis, as applicable)
Complies with EN 1041 (information supplied by the manufacturer of medical devices)
Complies with EN 60598 2 25 (particular requirements for luminaires for use in clinical areas of hospitals and health care buildings)
Meets 2014/35/EU Low Voltage Directive requirements
GMDN code: 12276 (examination light, non Sterile, reusable, as stated in product datasheet)
NHS E Class codes: FBU, FKR (per X4 Series datasheet)
LED examination light
Indications
General medical examination and assessment in primary care and outpatient settings
Illumination for minor procedures and treatments where high-quality, focused lighting is required
Use in hospital examination rooms, treatment rooms, emergency departments and wards
Use in specialist clinical environments such as dermatology, ENT, gynaecology and general practice when an examination light is required
Situations where flexible, wall-mounted medical lighting is preferred to ceiling or mobile configurations
Composition
LED light source (7 high-performance LEDs in the X4 Series light-head)
Wall-mounted bracket and spring-balanced suspension arm system (standard primary arm approximately 940 mm)
Fully-enclosed, smooth examination light-head with integrated BioProtect® antimicrobial coating on painted surfaces
Integrated electronic driver with input voltage 100–240 V AC, 50/60 Hz and output voltage approximately 30 V DC, 1 A
Mechanical wall mounting hardware interface designed for four M8 clearance fixings on the wall bracket (fixings supplied by installer according to surface)
Electrical cabling and control electronics providing single-handed on/off and variable intensity control from a switch adjacent to the light-head
Formulation
Medical device, non-sterile, non-drug electrical equipment
LED examination lighting system (X4 Series) configured as a wall-mounted unit (model X400LW)
Fixed wall installation with articulated arm and adjustable LED light-head
Packaging
1 x DARAY X400LW wall-mount LED examination light (X4 Series) with light-head, articulated arm and wall bracket
Integrated LED driver and control switch (on/off and variable intensity) located near the light-head
Product datasheet and installation/operation instructions supplied by the manufacturer
Mounting hardware requirements specified (wall fixings are selected by installer according to local wall construction and may not be supplied as standard)
Usage
Installation must be carried out by suitably qualified personnel in accordance with DARAY’s installation instructions and relevant electrical standards.
Mount the wall bracket at the recommended height (approximately 1900 mm from finished floor level to the underside of the wall mounting bracket) or as specified for the intended clinical use.
Secure the wall bracket using appropriate fixings for the wall type, ensuring load-bearing capacity and stability before attaching the arm and light-head.
Connect the electrical supply to the integrated driver using an appropriate 100–240 V AC, 50/60 Hz mains connection as instructed in the manufacturer’s documentation.
Once installed, use the spring-balanced arm to position the light-head over the examination area; adjust reach and angle by moving the arm and light-head as needed.
Switch the light on using the single-handed control located next to the light-head and adjust the light intensity within the approximate 5–100% range to suit the procedure.
Ensure the light field is correctly focused on the examination site, using the large diameter light field for uniform illumination and minimal shadowing.
After use, switch the light off using the control switch and reposition the arm to a parked position to reduce risk of accidental impact.
Clean the light-head, arm and painted surfaces regularly using approved cleaning agents compatible with the BioProtect® antimicrobial coating and follow local infection-prevention policies.
Do not attempt internal repairs or modifications; any servicing beyond routine cleaning and visual inspection should be performed by authorised service personnel or according to DARAY’s service guidance.
Contraindications
Not intended for use in areas with explosive atmospheres or where flammable anaesthetic mixtures are present unless explicitly approved in the manufacturer’s instructions.
Not suitable for use as a surgical operating theatre light where specific theatre lighting standards and performance requirements are mandated (it is an examination light).
Should not be installed or used where the wall or mounting structure cannot safely support the weight and operating loads of the arm and light-head.
Not designed for direct contact with patients or for use as a life-support device.
Adverse Effects
Incorrect installation or use contrary to the manufacturer’s instructions may increase the risk of mechanical instability, leading to potential falls or impact injuries.
Improper positioning or excessive intensity may cause temporary visual discomfort or glare for clinicians or patients.
Failure to follow cleaning and infection control instructions may compromise infection prevention in the clinical environment.
Storage Conditions
Store and operate in a dry, indoor clinical environment within the temperature and humidity ranges specified in the manufacturer’s instructions for use.
Protect the light from excessive dust, moisture, corrosive atmospheres and mechanical impact during storage and transport.
When not in use for extended periods, switch off the device and, if recommended by the manufacturer, isolate from the mains electrical supply.
Avoid covering the light-head or ventilation areas to prevent heat build-up during operation.
